Form 483

Synlait Milk Limited Form 483, 2024-09-06

FDA issued a Form 483 to Synlait Milk Limited on 2024-09-06 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Synlait Milk Limited · Rakaia, New Zealand · Issued September 6, 2024

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

6 Sep 2024
21 CFR 106.100(k)

Complaints procedures

Cited by Danny Tuntevski, Melinda B Lewis

6 Sep 2024
21 CFR 106.30(b)

Equipment, utensil - clean, sanitize

Cited by Danny Tuntevski, Melinda B Lewis

6 Sep 2024
21 CFR 106.30(e)(2)(i)

Cold storage areas - 40 degrees F

Cited by Danny Tuntevski, Melinda B Lewis

6 Sep 2024
21 CFR 106.30(g)

Filter - 0.5 micrometer or smaller, compressed gas

Cited by Danny Tuntevski, Melinda B Lewis

Inspected site

SMSynlait Milk LimitedRakaia, New Zealand

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 106.100(k)Cited across public-safe Form 483 observations1x
21 CFR 106.30(b)Cited across public-safe Form 483 observations1x
21 CFR 106.30(e)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 106.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere